NICM is a focal point for innovation and independent research offering a full range of commercial testing and product development services for complementary and integrative medicine, pharmaceuticals, and veterinary products.
As a full service research-intensive institute, from the bench to the bedside (preclinical, clinical and translational), we advance evidence-based analysis focusing on product quality, safety, efficacy, and effectiveness.
Our world-class researchers and state-of- the-art facilities at Western Sydney University offer novel, innovative and creative solutions for technical challenges faced by industry.
Read more in NICM's commercial services brochure (PDF, 1267.15 KB) (opens in a new window).
TGA Licenced Laboratory
NICM is one of only two university laboratories licensed by the Australian Therapeutic Goods Administration (TGA) to undertake and provide certificates of analysis for herbal products in line with regulatory requirements.
Our fully equipped laboratories support industry with independent and accredited testing and research services, including:
- Authentication of botanical identity of raw herbs and identification of active ingredients.
- Assay and Potency testing – Herbals, Active Pharmaceutical Ingredients and compounded pharmaceutical preparation in all dosage forms.
- Analytical method development and validation.
- Stability testing – physical and chemical; batch to batch quality assurance.
Our preclinical research capabilities extend to various novel in vivo and in vitro models.
Utilising a wide range of instruments and advanced techniques such as Nuclear Magnetic Resonance Spectroscopy and High Performance Liquid Chromatography systems, we provide a strong scientific foundation for product development.
NICM’s fully equipped laboratories support industry with independent and accredited testing and research services, including:
- Pre-formulation studies, excipient compatibility, physicochemical/chemical purity.
- Formulation studies, dosage form design.
- Extraction, isolation and quantification of herbal biomarkers.
- Herbal synergy and combination optimisation.
- Bioassay guided fractionation.
- Cell based antioxidant, anti-inflammatory, anti cancer, vascular health, neuronal and antimicrobial assays.
- Molecular targets studies underlying clinical effects of herbal medicines.
- Pharmacokinetic studies and bioavailability of herbal medicine.
- Herb-drug interaction studies.
- In vitro and in vivo toxicity testing.
Essential to the development of new interventions, clinical trials research verifies a product’s benefits and targeted indications, along with its limitations and precautions.
NICM can assist in developing your research program by providing a range of clinical research services, including:
- Clinical trials – ICH compliant, phase II and III.
- CRO services, including protocol development, trial design.
- Clinical bioavailability studies.
- Cardiovascular and neurological function testing using technologies such as electroencephalography (EEG), SphygmoCor and computer based cognition testing.
Therapeutic goods include goods Australians rely on every day, such as vitamin tablets and sunscreens, through to goods used to treat serious conditions, such as prescription medicines, vaccines, blood products and surgical implants.
NICM provide a range of regulatory services specialising in complementary medicines (also known as 'traditional' or 'alternative' medicines) include vitamin, mineral, herbal and aromatherapy products. Our services include:
- Ingredient and product formulation reviews and level of registration required.
- Product formulation for TGA compliance.
- Evidence packages and reviews for therapeutic indications/claims.
- Development and submission of listing applications to the TGA.
- Label development and review.
- Liaising with the TGA.
- Stability protocol development.
- Compliance of marketing materials and advertising clearance.
Assessed Listed Medicines
The TGA has implemented a new 'assessed listed medicines' pathway for sponsors to enter their products in the Australia Register of Therapeutic Goods (ARTG).
Medicines listed through the assessed listed medicines pathway will be included in the ARTG following self-certification of the safety and quality of the product, and TGA pre-market assessment of efficacy evidence supporting the proposed indications.
A key reform legislated in the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 (opens in a new window) is the establishment of an additional pathway for the regulation of intermediate-risk medicines.
This amendment will see the two-tiered system for the regulation of all medicines, including complementary medicines, transition to a three-tiered system, and provides a pathway for complementary medicines to have evidence of efficacy assessed by the TGA.
This change to the regulation of medicines in Australia is an important step as the new pathway will make it easier for consumers to differentiate between complementary medicines that have had evidence of efficacy assessed by an independent assessor – the TGA – and those that have not. The TGA’s positon is in line with the World Health Organization’s (WHO) guidelines on the role of traditional and complementary medicine.
The new assessment pathway will sit between the existing listed medicine (low risk) and registered medicine (high risk) pathways, providing sponsors with access to higher level indications than are available on the permitted indications list for low risk medicines.
The three pathways are broadly defined as follows:
- AUST-L (existing pathway - listed): Listing in the ARTG following self-declaration by the sponsor regarding safety, quality and efficacy.
- AUST-L(A) (new pathway – assessed listed): Listing in the ARTG following self-assessment of the safety and quality and a TGA assessment for efficacy and product label check.
- AUST-R (existing pathway - registered): Registration in the ARTG following full TGA assessment of safety, quality and efficacy.
NICM is well positioned to assist with regulatory support and compliance with the new assessed listed pathway by means of:
- Ingredient and product formulation reviews for AUST-L(A) compliance.
- Liaising with the TGA.
- Clinical trial protocol development.
- Clinical trial completion.
- Development and submission of AUST-L(A) applications to the TGA.
For more information, please visit the TGA website (opens in a new window) or contact (opens in a new window) our commercial services team.